Sources Sought Notice.pdf

SINGLE INSTITUTIONAL REVIEW BOARD (sIRB)

75N93022R00037

Sources Sought Reference Number:__75N93022R00037___________________

Type of Requirement

New Requirement Follow-on (Contract No.:______________) Other (specify):________________

Place of Performance

Place of performance is currently unknown Place of performance is known. Address or general location:______________

Recompetition (if applicable)

N/A

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-

Sources Sought Notice Information

Introduction

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

An organization that is not considered a small business under the applicable NAICS code 541715 should not submit a response to this notice.

A determination by the Government not to compete this requirement as a small business set-aside, based upon responses to this notice, is solely within the discretion of the Government.

Background

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by infectious agents, including research to counter bioterrorism. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded through a variety of research grants and contracts.

The evaluation of therapeutics, vaccines, devices, diagnostics and treatment strategies in clinical trials and studies is an essential element of the efforts of NIAID. Through multiple grant and contract research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 0-4 clinical trials of therapeutics and vaccines, including new vaccine formulations, schedules and modes of delivery; surveillance or natural history / cohort studies for pathogens of interest; and evaluation of novel diagnostics. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., SARS-CoV-2, Ebola, influenza, etc.), as well as those supporting the evaluation of the safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens).

The recent COVID-19 pandemic has underscored the need for rapid IRB review to support critical and time-sensitive clinical studies. To that end, DMID requires the services of a single institutional review board (IRB), also known as an independent ethics committee (IEC), to review the methods proposed for select NIAID-supported clinical research activities to ensure studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) are ethical and meet current Federal regulations.

Furthermore, NIH Policy requires the use of a single IRB for multi-site, non-exempt human subjects research using the same research protocol.

Purpose and Objectives

The contract(s) to be awarded under a Request for Proposal (RFP) for the requirements stated herein will provide single institutional review board (IRB) services to support select NIAID-supported clinical research activities. The Contractor shall provide all services necessary to serve as the IRB of record for US domestic sites for select NIAID studies throughout the conduct of the studies. At times, reviews may be urgent in order to respond to a public health emergency. The IRB contract shall be administered and used primarily to support DMID initiatives, however, NIAID may use the contract to support regulatory affairs services for domestic or international clinical research or clinical trials for high-priority NIAID research. The NIAID anticipates awarding one firm-fixed-unit-price Indefinite Delivery Indefinite Quantity (IDIQ) contract to fulfill the technical requirements. However, the NIAID reserves the right to award multiple IDIQ contracts or no contract.

NIAID anticipates awarding a Task Order for Task Area A (Project Management) and Task Area B (IRB Services) upon award of the IDIQ contract(s). Task orders for specific task areas will also be competed for issuance among the IDIQ pool after the award of IDIQ contract(s).

https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm

Task Area A Project Management Requirements

The Contractor shall provide on a firm-fixed-unit-price basis: a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all functions carried out under the contract to include:

1. Project management and administrative support

2. Oversight of secondary research involving biospecimens and data

Task Area B IRB Services Requirements

The contractor shall provide on a firm-fixed-unit-price basis all services necessary to serve as the IRB of record for US domestic sites for select NIAID studies throughout the conduct of such studies. Such services shall include:

1. Maintaining an IRB committee with the necessary scientific, ethical, technical and community expertise, education, and training to provide IRB full board or expedited review and board determinations

2. Providing urgent full board review and determinations upon request for select studies in response to public health needs

3. Providing upon request, Institutional Biosafety Committee services, Genetic Advisory Committee services, and certified translation services

Anticipated period of performance

The Government anticipates making one award. The anticipated start date is on/or about February 2024 with an ordering period of seven (7) years.

Capability statement/information sought

Capability statements submitted as a result of this notice must demonstrate the organization’s qualifications and experience, specifically providing evidence as to the organization’s capability to perform the requirements stated herein, with particular attention to the following areas:

1. Providing project management, administrative support, and oversight activities

2. Providing IRB services to include full board, expedited, and urgent reviews

3. Providing Institutional Biosafety Committee services, Genetic Advisory Committee services, and certified translation services

Capability statements should also include the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement;

(4) the capability to provide the required level-of-effort on a continuing and emerging needs basis; (5) resumes for proposed key personnel, which reflect education, and previous work relevant to the proposed requirement; and (6) a general description of the facilities and other resources needed to perform the work.

How to Submit a Response

1. Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed four (4) pages, excluding resumes. Tailored capability statements must also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address).

Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one inch on each edge of the paper. Print setup should be single sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such.

Responses will be reviewed only by NIH personnel and will be held in a confidential manner.

All information received within fifteen (15) days after the date of publication of this synopsis will be considered by the Government.

2. Required Business Information:

• Unique Entity ID (UEI).

• Company Name.

• Company Address.

• Company Point of Contact, Phone and Email address

• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.

• Do you have a government approved accounting system? If so, please identify the agency that approved the system.

• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/SAM/pages/public/index.jsf. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).

3. Number of Copies:

Please submit one (1) electric copy of your response as follows:

• For this Small Business Sources Sought notice, the NIAID requires capability statements to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

• For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."

4. Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 3:00pm (Eastern Prevailing Time) on January 20, 2023. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND

TIME MAY NOT BE CONSIDERED AT THE DISCRETION OF THE CONTRACTING OFFICER.

https://www.sam.gov/SAM/pages/public/index.jsf https://ecps.nih.gov/ https://ecps.nih.gov/

Disclaimer and Important Notes

This notice does not obligate the Government to award an IDIQ contract or Task Order or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published at SAM.gov. However, responses to this notice will not be considered responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Points of Contact:

Inquiries concerning this notice may be directed to:

Ms. Mary Smith, Contract Specialist Ph: 240-627-3377 Email: mary.smith@nih.gov

Mr. Greg Durham, Contract Specialist Ph: 240-747-7677 Email: greg.durham@nih.gov